澳大利亚与小儿鞘内注射巴氯芬相关的不良事件：5年数据收集
Adverse events associated with paediatric intrathecal baclofen in Australia: 5 years of data collection.
作者信息
Tyack Louise, Copeland Lisa, McCartney Lynn, Waugh Mary-Clare
机构信息
Queensland Paediatric Rehabilitation Service, Queensland Children's Hospital, Brisbane, Queensland, Australia.
Kids Rehab, The Sydney Children's Hospitals Network Randwick and Westmead, Sydney, New South Wales, Australia.
出版信息
J Paediatr Child Health. 2021 Feb;57(2):258-262. doi: 10.1111/jpc.15194. Epub 2020 Sep 25.
AIM
This study aims to examine the adverse event (AE) rate for intrathecal baclofen (ITB) therapy in an Australian paediatric population and to clarify type and frequency of AEs.
METHODS
AE data were extracted from the Australian Paediatric ITB Research Group national database, to include the first 5 years of data collection. Raw data were collated and analysed descriptively.
RESULTS
Data were collected for 40 patients. Forty-seven AEs in 23 patients were reported. Ten (25%) patients required surgical intervention related to their AE. Five patients (12.5%) required pump removal. The most frequent ITB-related AEs were catheter dysfunction (24%), drug overdose, withdrawal or sensitivity (19%), seromas and haematomas (15%) and infections (13%).
CONCLUSIONS
The AE rate for ITB therapy is high and needs to be considered when counselling patients regarding ITB as a therapeutic option.
目的
本研究旨在调查澳大利亚儿科人群鞘内注射巴氯芬（ITB）治疗的不良事件（AE）发生率，并明确不良事件的类型和频率。
方法
从澳大利亚儿科ITB研究组国家数据库中提取AE数据，包括最初5年的收集数据。对原始数据进行整理并进行描述性分析。
结果
收集了40例患者的数据。报告了23例患者发生的47起不良事件。10例（25%）患者因不良事件需要手术干预。5例患者（12.5%）需要移除泵。最常见的与ITB相关的不良事件是导管功能障碍（24%）、药物过量、戒断或敏感（19%）、血清肿和血肿（15%）以及感染（13%）。
结论
ITB治疗的不良事件发生率较高，在向患者咨询将ITB作为一种治疗选择时需要考虑这一点。
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